Manufacturing Changes Sample Clauses
The Manufacturing Changes clause defines the procedures and requirements for making alterations to the manufacturing process, materials, or specifications of a product. Typically, this clause requires the manufacturer to notify the buyer in advance of any proposed changes and may require the buyer's approval before implementation. For example, if a supplier wants to switch to a new component or adjust production methods, they must follow the agreed notification and approval process. This clause ensures that product quality and compliance are maintained, and it helps prevent disruptions or unexpected variations in the delivered goods.
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Manufacturing Changes. (a) Licensee may unilaterally and in its sole discretion make one or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee.
(b) Quoin shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change in accordance with the specifications provided by Quoin to Licensee. All costs arising out of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quoin.
Manufacturing Changes. Corium shall notify ▇▇▇▇ in the event it desires to make any changes in the manufacturing process as set forth in the ANDA for the Product. No such change shall be made unless ▇▇▇▇ authorizes such change.
Manufacturing Changes. Both TI and Anam understand that the particular TI Product to be provided to TI for initial Product Qualification and as qualified by TI will define the applicable manufacturing process with respect to the manufacture of TI Products. After Product Qualification is successfully completed, Anam shall not make any changes to said manufacturing process(es) or the Specifications without the prior written instruction and consent of TI. Any unauthorized manufacturing changes by Anam which affect the form, fit, function or reliability of the TI Products shall render them unqualified. TI assumes no liability for the manufacture of unqualified TI Products. Any particular TI Product and its manufacture can become unqualified after Product Qualification if such formerly qualified TI Product subsequently falls below applicable Specifications. Changes to a particular TI Product or its manufacture may necessitate re-qualification. TI or Anam shall bear the costs associated with the foregoing as determined under the applicable TAA and this Agreement.
Manufacturing Changes. Supplier shall have the right to make changes to the materials, equipment or methods of production or testing used in the Manufacture of API to be supplied to Customer from time to time, and shall notify Customer thereof in advance no less than three (3) months prior to the first delivery to Customer of API implementing such change(s). Supplier shall first obtain Customer’s prior written consent to any such change (other than a change required by a Regulatory Authority) that would affect Customer’s then pending Regulatory Filing(s) or in-process pre-marketing clinical trial for a Recro Product. Following grant of Regulatory Approval, Supplier shall first obtain Customer’s prior written consent to any such changes (other than a change required by a Regulatory Authority) that would affect Customer’s Regulatory Approval(s), such consent not to be unreasonably withheld. Customer recognizes that change may be necessary to enable Supplier to remain efficient and cost-effective and thus shall be fully supportive of the implementation of such changes where justified.
Manufacturing Changes. BIONICHE may implement commercially reasonable changes in the equipment used for Manufacturing of the Drug Product in the Facility, or the Manufacturing methods, labeling, or packaging of the Drug Product only as expressly provided in the Specifications unless BIONICHE has the prior written consent of CUMBERLAND, which consent shall not be unreasonably withheld or delayed.
Manufacturing Changes. During the Term, OXIS shall not make any material changes to its manufacturing operations for Licensed Product without the prior written consent of HAPTOGUARD, which consent shall not be unreasonably withheld.
Manufacturing Changes. Seller shall give Buyer not less than sixty (60) days prior, written notice of any specification, design, part number or other identification changes, or any major changes in process or procedure or changes in the location of the manufacturing plant or place where Seller performs any of its obligations under this Order if any such changes may affect the Goods.
Manufacturing Changes. Kin Yat shall not make any changes to the manufacturing process that may affect the product form, fit, function or safety without receiving prior written approval from iRobot.
Manufacturing Changes. (i) SITE AND RESPONSIBILITY. ▇▇▇▇▇▇▇ shall not change the site of manufacture of the Products without VisiJet's prior written approval, which shall not be unreasonably withheld or delayed. ▇▇▇▇▇▇▇ shall not assign or subcontract manufacturing responsibility without VisiJet's prior written approval, which shall not be unreasonably withheld or delayed. For purposes of this Section, the "site of manufacture" and "manufacturing responsibility" shall mean the location and responsibility for the final assembly and quality testing of the Products.
Manufacturing Changes. The supplier must notify Distell of their intention to make any change that may affect the specification, safety, quality, security, shelf-life or functionality of material produced, such as changes in raw materials, services, parts, manufacturing line, manufacturing facility or processes and any change shall be approved by Distell before being implemented. Distell must be notified of such changes in writing. Distell will assess whether a new approval is needed.